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Non-Invasive Ventilation After Extubation in Hypercapnic Patients

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00539708
First received: October 3, 2007
Last updated: May 6, 2008
Last verified: May 2008

October 3, 2007
May 6, 2008
May 2005
January 2008   (final data collection date for primary outcome measure)
Primary outcome: The incidence of respiratory failure after extubation [ Time Frame: 3 days after extubation ] [ Designated as safety issue: No ]
Primary outcome: The incidence of respiratory failure after extubation [ Time Frame: 3 days after extubation ]
Complete list of historical versions of study NCT00539708 on ClinicalTrials.gov Archive Site
Survival [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Survival [ Time Frame: 90 days ]
Not Provided
Not Provided
 
Non-Invasive Ventilation After Extubation in Hypercapnic Patients
Non-Invasive Ventilation After Extubation in Hypercapnic Patients

The purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.

Background and aims: Patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (ICU), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality. We will assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in these patients. Design: Prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group). Subjects: Patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (PaCO2 >45 mmHg) during the spontaneous breathing trial, ready to be extubated. Interventions: Random allocation into two groups: NIV immediately after extubation during 24 hours, on conventional clinical management. Clinical follow-up (incidence of extubation failure, reintubation, ICU and hospital mortality, 90-day survival, complications associated to mechanical ventilation, ICU and hospital length of stay). Analyses of data: Comparison between two groups (NIV and control) in non-paired data design: quantitative variables (t-test, Mann-Whitney test, ROC curves), qualitative or categorical variables (chi square, Fisher's exact test), and Kaplan-Meier estimate of survival curves).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Respiratory Failure
Procedure: Non-invasive ventilation
Non-invasive ventilation after extubation for 24 hours
  • Experimental: NIV
    Non-invasive ventilation
    Intervention: Procedure: Non-invasive ventilation
  • Active Comparator: Control
    Oxygen therapy
    Intervention: Procedure: Non-invasive ventilation
Ferrer M, Sellarés J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. Epub 2009 Aug 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
April 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic respiratory disorders with invasive mechanical ventilation
  • Hypercapnic respiratory failure during successful spontaneous breathing trial

Exclusion Criteria:

  • Face or cranial trauma or surgery
  • Recent gastric or esophageal surgery
  • Tracheostomy or other upper airway disorders
  • Upper gastrointestinal bleeding
  • Excess respiratory secretions
  • Lack of collaboration
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00539708
FIS 041130
No
Miquel Ferrer, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Fondo de Investigacion Sanitaria
Principal Investigator: Miquel Ferrer, MD, PhD UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona
Hospital Clinic of Barcelona
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP